In a one-two punch for Bayer, cost watchdogs in England and Germany rejected the company’s new “tumor-agnostic” cancer drug Vitrakvi because of its price and “limitations” in its supporting data.
England’s National Institute for Health and Care Excellence (NICE), in draft guidance published Friday, said cost-effectiveness calculations for the pricey med are “very uncertain," adding that the drug’s benefit over existing treatment options is unknown. Germany’s cost-effectiveness agency, IQWiG, also rejected the med on insufficient data.
Bayer’s Vitrakvi treats cancers throughout patients’ bodies that feature an NTRK gene fusion. As NICE sees it, there’s no existing standard treatment in that class, so current treatment is based on where the cancer begins.
Evidence showed NTRK gene fusion cancers shrink after treatment with Bayer's med, but NICE says it’s “difficult to know how well [Vitrakvi] works because it has not been compared in the trials with other treatments.”
The drug, also known as larotrectinib, costs £15,000 per 30-day supply, NICE says, and Bayer offered a “commercial arrangement” in the event the drug was recommended. NICE estimates around 600 to 700 patients suffer from NTRK gene fusion cancers in England.
In the draft guidance, the agency concluded that Bayer’s new therapy does not have “the potential to be a cost-effective use of NHS resources,” so it rejected the drug through routine use or through the Cancer Drugs Fund.
It’s “disappointing that Bayer has not yet been willing to price larotrectinib at a level which represents value for the NHS and the taxpayer, however, should they reconsider, the NHS’ door remains open for further discussion,” NHS’ national director of specialized commissioning John Stewart said in a statement.
Looking forward, NHS is preparing for similar “next-generation therapies,” Stewart said, including “constructive conversations with Roche" on its tumor-agnostic drug, Rozlytrek.
While Bayer said it's disappointed with the decision, the company argued it's "not surprising" because "NICE methods are not yet appropriate for appraising histology independent products."
"We will continue to consult with NICE and hope that going forward a positive NICE appraisal will be granted," the company said.
Bayer's Vitrakvi won U.S. approval in November 2018 and European approval in September 2019. Loxo Oncology originally developed the drug, and Bayer picked up full rights to the med when Eli Lilly bought that drugmaker, along with an in-development IRK inhibitor.
Further, on Friday Bayer hit a setback in its home country as cost watchdogs at IQWiG rejected the med on insufficient data, citing concerns over a lack of control arms in clinical trials.
While Vitrakvi was first in the NTRK gene fusion cancer market, it’s now competing against Roche in the U.S. That drugmaker won an FDA nod for Rozlytrek in August 2019 and priced its med at a discount to Bayer’s option. Roche's drug hasn’t yet won European approval.